The aim of this study is to assess the benefits from the AAISafeR/SafeR algorithm of Symphony 2550 or REPLY DR in a wide range of pacemaker patients.

The expected benefits will be a result of the reduction of the percentage of ventricular pacing.

It contributes to the longevity of the cardiac pacemaker and has an effect on the incidence of sustained (or persistent) Atrial Fibrillation and Heart Failure. These clinical benefits are a result of spontaneous ventricular activation which ensures a more physiological ventricular activation.

The benefits will be assessed by comparing the incidence of atrial arrhythmias and the evolution of the haemodynamic status of the patients (QOL, echo and BNP)

Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication

Further study details as provided by Sorin Group:

Primary Outcome Measures:

The outcome measure is the % of ventricular pacing and hospitalizations for specified cardiac reasons (symptomatic AF, cardioversions for AF and heart failure) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Patient implanted with a bipolar right atrial lead and a right ventricular lead

Patient has signed a consent form after having received the appropriate information

Exclusion Criteria:

Patient with permanent AF

Patient suffering from sustained ventricular arrhythmias

Patient with congenital complete heart block

Patient with vasovagal syncope, carotid sinus syndrome

Patient with AV node ablation

Patient having suffered from a myocardial infarction within the last month

Patient suffering from severe aortic stenosis

Patient suffering from unstable angina pectoris

Patient is not able to understand the study objectives and protocol or refuses to co-operate

Patient is not available for scheduled follow-up

Patient has a life expectancy less than one year

Patient is included into another clinical study

Patient is minor, this is < 18 years

Patient is a pregnant woman

Any patient with a contra-indication for the device labeling

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562107